510(k) Report

510(k) · Cleared

Recalled · 2009

Surgassist Flexshaft 2, Model FS2 14

K021249510(k) SpecialCleared May 15, 200226-day reviewClass II21 CFR 878.4750Recalls 1

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 May 15, 2002 as substantially equivalent to K003277 (Powermed, Inc., 2000) and 1 other predicate after a 26-day review. Its family tree reaches back 2 generations to 1989. 22 later devices descend from it. It has been recalled once.

Decided
May 15, 2002
Review
26 days
Class
Class II
Product code
GDW
Recalls
1
Predicates
2

Its longest line of descent runs back 2 generations to K890841 (1989). 4 ancestors in all. 22 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1991: 1 other ancestor2007: 3 descendants cleared2008: 2 descendants cleared2011: 1 descendant cleared2009: 1 descendant cleared2010: 1 descendant cleared2015: 1 descendant cleared2018: 1 descendant cleared2017: 2 descendants cleared2014: 2 descendants cleared2012: 2 descendants cleared2021: 1 descendant cleared2016: 2 descendants cleared2020: 2 descendants cleared2026: 1 descendant clearedK890841 · Titanium Staples · ETHICON, Inc. · 1989K012809 · Surgassist Right Angle Linear Cutter Dlu - 45MM, Model RALC45 · Power Medical Interventions, Inc. · 20011990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 6 descendants3 generations forward: 5 descendants4 generations forward: 2 descendants5 generations forward: 3 descendants6 generations forward: 4 descendants7 generations forward: 1 descendant K012809 · Surgassist Right Angle Linear Cutter Dlu - 45MM, Model RALC45 · Power Medical Interventions, Inc. · 2001K890841 · Titanium Staples · ETHICON, Inc. · 19890+5
  1. Root · 2 generations backK890841 Titanium StaplesETHICON, Inc. · 1989
  2. 1 generation backK012809 Surgassist Right Angle Linear Cutter Dlu - 45MM, Model RALC45Power Medical Interventions, Inc. · 2001
  3. This deviceK021249 Surgassist Flexshaft 2, Model FS2 14Power Medical Interventions, Inc. · 2002
  4. Descendant · cites it directly · 21 of its ownK071708 I45, I45S, I60, and I60SPower Medical Interventions, Inc. · 2007 · Recalled
  5. Descendant · 2 generations on · 11 of its ownK073001 Idrives, Idrivec, IdrivefPower Medical Interventions, Inc. · 2007 · Recalled
  6. Descendant · 3 generations on · 9 of its ownK102325 Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload)Covidien, LLC, Formerly Registered AS Tyco Healthca · 2010
  7. Descendant · 4 generations on · 8 of its ownK121510 Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H · 2012
  8. Descendant · 5 generations on · 5 of its ownK160176 Signia StaplerCovidien · 2016 · Recalled

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2007: 32008: 22009: 12010: 12011: 12012: 22014: 22015: 12016: 22017: 22018: 12020: 22021: 12026: 1
2007high 3 (2007) · low 0 (2013)2026

Most influential descendants

Showing 5 of 22 · See all
  • K071708I45, I45S, I60, and I60SPower Medical Interventions, Inc. · 2007 · cites it directly21descendants
  • K073001Idrives, Idrivec, IdrivefPower Medical Interventions, Inc. · 2007 · 2 generations on11descendants
  • K102325Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload)Covidien, LLC, Formerly Registered AS Tyco Healthca · 2010 · 3 generations on9descendants
  • K121510Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H · 2012 · 4 generations on8descendants
  • K160176Signia StaplerCovidien · 2016 · 5 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K890841Titanium StaplesETHICON, Inc.1989—
−1K012809Surgassist Right Angle Linear Cutter Dlu - 45MM, Model RALC45Power Medical Interventions, Inc.2001—
0 (this device)K021249Surgassist Flexshaft 2, Model FS2 14Power Medical Interventions, Inc.2002—
+1K071708I45, I45S, I60, and I60SPower Medical Interventions, Inc.20071
+2K073001Idrives, Idrivec, IdrivefPower Medical Interventions, Inc.20071
+3K102325Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload)Covidien, LLC, Formerly Registered AS Tyco Healthca2010—
+4K121510Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H2012—
+5K160176Signia StaplerCovidien201614

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200730
200820
200910
201010
201110
201220
201420
201510
201620
201720
201810
202020
202110
202610
FIG. 1 — Lineage of K021249, 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? (2)

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
…ler, GAG 3) Predicate Devices: a) SurgASSIST™ System with Circular Stapler Disposable Loading Unit with Titanium Implantable Staple, Power Medical Interventions, Inc., K003277. 000016 (OAEATT (£ R0FY) Power Medical Interventions, Inc. SurgASSIST™ System with FlexShaft 2 Special 510(k) D…
Powermed, Inc.20003
*K012809Surgassist Right Angle Linear Cutter Dlu - 45MM, Model RALC45
Summary page 7
…nded use for this product modification will be substantially identical to that of Power Medical Interventions, Inc. immediate predicate 510(k) Notification’s, K003277 & K012809). The SdrgASSlSTTM System with Circular Stapler Digital Loading Unit™ (DLU), has applications throughout the alimentary tract fo…
Power Medical Interventions, Inc.2001—

Also cleared against K003277: 6 other devices →

What descends from it? (22)

See all 22

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K071708I45, I45S, I60, and I60SPower Medical Interventions, Inc.200721

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

Recalls of this device

DateClassRecallRoot causeReason
Sep 23, 2009Not classifiedZ-0397-2010Nonconforming Material/ComponentLack of assurance that products were manufactured under GMPs. This action is being undertaken due to certain products potentially exhibiting compromised staple formation or cutting which in some instances may result in extended surgical…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 12.5 years on median.
  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K071708 (Power Medical Interventions, Inc., 2007) has gone furthest, with 21 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 Circular Stapler Digital Loading Unit™ (DLU), has applications throughout the alimentary tract for end-to-end and side-to-side anastomosis.

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 anastomosis.

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
  • K020343Surgassist System; Wireless Remote Control (Component); Wired Remote ControlPower Medical Interventions, Inc. · 20021 recall
  • K012809Surgassist Right Angle Linear Cutter Dlu - 45MM, Model RALC45Power Medical Interventions, Inc. · 2001

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/K021249 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021249: Surgassist Flexshaft 2, Model FS2 14.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021249

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026