510(k) Report

510(k) · Cleared

Cleared

Surgassist Right Angle Linear Cutter Dlu - 45MM, Model RALC45

K012809510(k) TraditionalCleared Oct 26, 200165-day reviewClass II21 CFR 878.4750

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Power Medical Interventions, Inc. · GDW Staple, Implantable

Cleared on Oct 26, 2001 as substantially equivalent to K003277 (Powermed, Inc., 2000) and 2 other predicates after a 65-day review. Its family tree reaches back 1 generation to 1989. 66 later devices descend from it.

Decided
Oct 26, 2001
Review
65 days
Class
Class II
Product code
GDW
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K890841 (1989). 3 ancestors in all. 66 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1991: 1 other ancestor2002: 5 descendants cleared2005: 2 descendants cleared2010: 3 descendants cleared2006: 3 descendants cleared2003: 1 descendant cleared2004: 2 descendants cleared2007: 4 descendants cleared2012: 4 descendants cleared2008: 2 descendants cleared2009: 2 descendants cleared2019: 2 descendants cleared2011: 1 descendant cleared2016: 6 descendants cleared2014: 4 descendants cleared2015: 3 descendants cleared2018: 4 descendants cleared2017: 5 descendants cleared2020: 2 descendants cleared2013: 1 descendant cleared2023: 3 descendants cleared2021: 2 descendants cleared2026: 3 descendants cleared2025: 1 descendant cleared2022: 1 descendant clearedK890841 · Titanium Staples · ETHICON, Inc. · 19891990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 6 descendants2 generations forward: 6 descendants3 generations forward: 15 descendants4 generations forward: 16 descendants5 generations forward: 9 descendants6 generations forward: 4 descendants7 generations forward: 1 descendant8 generations forward: 1 descendant9 generations forward: 1 descendant10 generations forward: 1 descendant11 generations forward: 1 descendant12 generations forward: 3 descendants13 generations forward: 2 descendants K890841 · Titanium Staples · ETHICON, Inc. · 19890+5+10
  1. Root · 1 generation backK890841 Titanium StaplesETHICON, Inc. · 1989
  2. This deviceK012809 Surgassist Right Angle Linear Cutter Dlu - 45MM, Model RALC45Power Medical Interventions, Inc. · 2001
  3. Descendant · cites it directly · 47 of its ownK020719 Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM…Power Medical Interventions, Inc. · 2002 · Recalled
  4. Descendant · 2 generations on · 46 of its ownK030653 Surgassist Straight Linear Stapler and Straight Linear 4 Row NO…Power Medical Interventions, Inc. · 2003
  5. Descendant · 3 generations on · 45 of its ownK040398 Surgassist Straight Linear 4 Row NO Knife Dlus with ReloadsPower Medical Interventions, Inc. · 2004
  6. Descendant · 2 generations on · 25 of its ownK040720 Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30…Power Medical Interventions, Inc. · 2004 · Recalled
  7. Descendant · cites it directly · 22 of its ownK021249 Surgassist Flexshaft 2, Model FS2 14Power Medical Interventions, Inc. · 2002 · Recalled

Showing 5 of 66 descendants. See all descendants

Descendants cleared per year

2002: 52003: 12004: 22005: 22006: 32007: 42008: 22009: 22010: 32011: 12012: 42013: 12014: 42015: 32016: 62017: 52018: 42019: 22020: 22021: 22022: 12023: 32025: 12026: 3
2002high 6 (2016) · low 0 (2024)2026

Most influential descendants

Showing 5 of 66 · See all
  • K020719Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM, 30MM with Blue and…Power Medical Interventions, Inc. · 2002 · cites it directly47descendants
  • K030653Surgassist Straight Linear Stapler and Straight Linear 4 Row NO Knife Digital Loading…Power Medical Interventions, Inc. · 2003 · 2 generations on46descendants
  • K040398Surgassist Straight Linear 4 Row NO Knife Dlus with ReloadsPower Medical Interventions, Inc. · 2004 · 3 generations on45descendants
  • K040720Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55 MM, 75 MMPower Medical Interventions, Inc. · 2004 · 2 generations on25descendants
  • K021249Surgassist Flexshaft 2, Model FS2 14Power Medical Interventions, Inc. · 2002 · cites it directly22descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K890841Titanium StaplesETHICON, Inc.1989—
0 (this device)K012809Surgassist Right Angle Linear Cutter Dlu - 45MM, Model RALC45Power Medical Interventions, Inc.2001—
+1K020719Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM, 30MM with…Power Medical Interventions, Inc.20021
+2K030653Surgassist Straight Linear Stapler and Straight Linear 4 Row NO Knife Digital…Power Medical Interventions, Inc.2003—
+3K040398Surgassist Straight Linear 4 Row NO Knife Dlus with ReloadsPower Medical Interventions, Inc.2004—
+2K040720Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55…Power Medical Interventions, Inc.20041
+1K021249Surgassist Flexshaft 2, Model FS2 14Power Medical Interventions, Inc.20021

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200250
200310
200420
200520
200630
200740
200820
200920
201030
201110
201240
201310
201440
201530
201660
201750
201840
201920
202020
202120
202210
202330
202510
202630
FIG. 1 — Lineage of K012809, 1989–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GDW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GDW device

  1. #1 K253657 Tri-staple 2.0™ Reloads; Endo GIA™ Reloads…score 15.1 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K003277Surgassist System with Circular Stapler Disposable Loading Unit, Model CS21,CS25,CS29,CS33
Summary page 1
…TTERS / STAPLING INSTRUMENTS A. SurgASSIST™ System, Circular Stapler Digital Loading Unit. Power Medical Interventions, Inc., New Hope, PA. REF CS21, CS25, CS29, CS33. (K003277) 0015 KO 2304 (£3,003) Power Medical Interventions, Inc. SurgASSIST™ Right Angle Linear Cutter DLU 510(k), Aug…
Powermed, Inc.20003
*K890841Titanium Staples
Summary page 2
…ght Angle Linear Cutter DLU 510(k), August-17-01 B. Proximate® Linear Cutter and Four Row with Safety Lock-Out. Ethicon Endo-Surgery, Inc., Cincinnati, Ohio. REF TLC55 (K890841) C. United States Surgical Powered Endoscopic GIA Stapler. United States Surgical Corp., Norwalk, CT. ( K913802). 4) Device Des…
ETHICON, Inc.1989—
*K913802Auto Suture (R) Powered Endoscopic Gia (TM) Stapler
Summary page 2
…Ethicon Endo-Surgery, Inc., Cincinnati, Ohio. REF TLC55 (K890841) C. United States Surgical Powered Endoscopic GIA Stapler. United States Surgical Corp., Norwalk, CT. ( K913802). 4) Device Description: The SurgASSIST™ System with Right Angle Linear Cutter Digital Loading Unit™ (DLU) is a cutter/stapler…
United States Surgical, A Division of Tyco Healthc1991—

Also cleared against K003277: 6 other devices →

What descends from it? (66)

See all 66

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K020719Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM, 30MM with Blue and…Power Medical Interventions, Inc.200247
K021249Surgassist Flexshaft 2, Model FS2 14Power Medical Interventions, Inc.200222
K020343Surgassist System; Wireless Remote Control (Component); Wired Remote ControlPower Medical Interventions, Inc.200213
K102325Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload)Covidien, LLC, Formerly Registered AS Tyco Healthca20109
K021701Surgassist Right Angle Linear Cutter 30MM, 45MM & 60MM, Models RALC30, RALC45 & RALC60Power Medical Interventions, Inc.20025
K052910Power Right Angle Linear Cutter Digital Loading Unit with ReloadsPower Medical Interventions, Inc.20050

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K020719 (Power Medical Interventions, Inc., 2002) has gone furthest, with 47 descendants of its own.
  • 6 other devices also cite its predicate K003277.

How does its category compare?

All GDW devices

GDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GDW

3in 2025

2007: 82008: 72009: 132010: 102011: 112012: 92013: 132014: 152015: 82016: 112017: 132018: 72019: 122020: 102021: 92022: 72023: 42024: 22025: 32026 (partial year): 3
2007high 15 (2014) · low 2 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GDW

111in 2025

2007: 56 days median2008: 57 days median2009: 27 days median2010: 39 days median2011: 49 days median2012: 45 days median2013: 49 days median2014: 63 days median2015: 111 days median2016: 96 days median2017: 103 days median2018: 90 days median2019: 205 days median2020: 88 days median2021: 233 days median2022: 89 days median2023: 267 days median2025: 111 days median2026 (partial year): 141 days median
2007high 267 (2023) · low 27 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GDW

3in 2025

2007: 92009: 222010: 22011: 92012: 11, 1 Class I2013: 12015: 62016: 22017: 32018: 32019: 4, 4 Class I2020: 112023: 12025: 3
2007high 22 (2009) · low 0 (2008)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · GDW

11,905in 2025

2007: 2,4012008: 2,3802009: 4,0142010: 3,7682011: 3,8262012: 3,7172013: 3,7772014: 4,7842015: 4,8992016: 5,1062017: 11,6432018: 14,9142019: 16,6002020: 12,3322021: 13,0152022: 13,6052023: 14,6232024: 13,2802025: 11,905
2007high 16,600 (2019) · low 2,380 (2008)2025

MAUDE reports naming product code GDW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200785692,401
200875702,380
20091327224,014
2010103923,768
2011114993,826
201294511 (1)3,717
2013134913,777
2014156304,784
2015811164,899
2016119625,106
201713103311,643
2018790314,914
2019122054 (4)16,600
202010881112,332
20219233013,015
2022789013,605
20234267114,623
20242—013,280
20253111311,905
202631410—

What is it indicated for?

The SurgASSIST™ System with Right Angle Linear Cutter DLU has applications in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K003277

6 other devices cite the same predicate.

  • K071708I45, I45S, I60, and I60SPower Medical Interventions, Inc. · 20071 recall
  • K061649Power Circular Stapler Digital Loading Unit with and Without SheathPower Medical Interventions, Inc. · 2006
  • K040024Surgassist Circular Stapler Digital Loading Units - 29 MM, Model CS29Power Medical Interventions, Inc. · 20041 recall
  • K032701Surgassist Circular Stapler Digital Loading Units (CS21, CS25, CS29, CS33)Power Medical Interventions, Inc. · 20033 recalls
  • K021249Surgassist Flexshaft 2, Model FS2 14Power Medical Interventions, Inc. · 20021 recall
  • K020343Surgassist System; Wireless Remote Control (Component); Wired Remote ControlPower Medical Interventions, Inc. · 20021 recall

More from Power Medical Interventions, Inc.

22 FDA decisions under this applicant name. See the company

  • K091215Intelligent Power Unit, Intelligent Console, Intelligent Delivery System, Intelligent Surgical InstrumentPower Medical Interventions, Inc. · 20091 recall
  • K083527Intelligent Articulating Endoscopic Linear Cutter Reverse with ReloadsPower Medical Interventions, Inc. · 20081 recall
  • K081826Intelligent Straight and Articular Endoscopic Linear Cutters, Vascular with Reloads, Models I30V, I45V…Power Medical Interventions, Inc. · 20081 recall
  • K073001Idrives, Idrivec, IdrivefPower Medical Interventions, Inc. · 20071 recall
  • K073148Idrives, Idrivec, Idrivef with Vascular IndicationsPower Medical Interventions, Inc. · 2007

Recent decisions in GDW

The GDW category page

  • K254291easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic…Ezisurg Medical Co., Ltd. · 2026
  • K260196ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICON™ Circular Stapler…Ethicon Endo-Surgery, LLC · 2026
  • K253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads…Covidien (Part of Medtronic) · 2026
  • K252739ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000…Ethicon Endo-Surgery, LLC · 2025
  • K250835ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm…Ethicon Endo-Surgery, LLC · 2025

https://510kreport.com/device/K012809 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012809: Surgassist Right Angle Linear Cutter Dlu - 45MM, Model RALC45.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012809

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026