510(k) Report

510(k) · Cleared

Cleared

Grasp Forceps/Scissors/Needle Holder/Dissector

K931340510(k) TraditionalCleared Jul 1, 1993107-day reviewClass II21 CFR 876.1500

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

Baxter Healthcare Corp · GCS Endoscope, Battery-Powered And Accessories

Cleared on Jul 1, 1993 after a 107-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 278 devices in its family, counting itself, has a Class I recall. 277 later devices descend from it.

Decided
Jul 1, 1993
Review
107 days
Class
Class II
Product code
GCS
Recalls
None
Predicates
0

277 later devices descend from it, 3 citing it directly. 1 of the 278 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2000: 1 descendant cleared2012: 6 descendants cleared1999: 1 descendant cleared2013: 8 descendants cleared2006: 3 descendants cleared2004: 4 descendants cleared2009: 3 descendants cleared2001: 1 descendant cleared2008: 7 descendants cleared2002: 4 descendants cleared2011: 8 descendants cleared2005: 5 descendants cleared2014: 12 descendants cleared2010: 3 descendants cleared2018: 18 descendants cleared2025: 31 descendants cleared2024: 22 descendants cleared2017: 15 descendants cleared2022: 18 descendants cleared2019: 12 descendants cleared2016: 11 descendants cleared2020: 19 descendants cleared2021: 17 descendants cleared2015: 6 descendants cleared2026: 23 descendants cleared2023: 19 descendants cleared, 1 with a Class I recall11990200020102020
  1. This deviceK931340 Grasp Forceps/Scissors/Needle Holder/DissectorBaxter Healthcare Corp · 1993
  2. Descendant · cites it directly · 269 of its ownK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
  3. Descendant · 2 generations on · 260 of its ownK022574 Intuitive Surgical Endoscopic Instrument Control System & Endoscopic…Intuitive Surgical, Inc. · 2002
  4. Descendant · 2 generations on · 260 of its ownK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
  5. Descendant · 2 generations on · 258 of its ownK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
  6. Descendant · 2 generations on · 254 of its ownK013416 Intuitive Surgical Endowrist Endoscopic Instrument FamilyIntuitive Surgical, Inc. · 2002

Showing 5 of 277 descendants. See all descendants

Descendants cleared per year

1999: 12000: 12001: 12002: 42004: 42005: 52006: 32008: 72009: 32010: 32011: 82012: 62013: 82014: 122015: 62016: 112017: 152018: 182019: 122020: 192021: 172022: 182023: 192024: 222025: 312026: 23
1999high 31 (2025) · low 0 (2003)2026

Class I recalls in this family

  • K223095 Senhance Surgical System4 generations on · 2023

Most influential descendants

Showing 5 of 277 · See all
  • K990144Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument…Intuitive Surgical, Inc. · 2000 · cites it directly269descendants
  • K022574Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model…Intuitive Surgical, Inc. · 2002 · 2 generations on260descendants
  • K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · 2 generations on260descendants
  • K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic…Intuitive Surgical, Inc. · 2004 · 2 generations on258descendants
  • K013416Intuitive Surgical Endowrist Endoscopic Instrument FamilyIntuitive Surgical, Inc. · 2002 · 2 generations on254descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K931340Grasp Forceps/Scissors/Needle Holder/DissectorBaxter Healthcare Corp1993—
+1K990144Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic…Intuitive Surgical, Inc.20003
+2K022574Intuitive Surgical Endoscopic Instrument Control System & Endoscopic…Intuitive Surgical, Inc.2002—
+2K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc.200218
+2K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc.2004—
+2K013416Intuitive Surgical Endowrist Endoscopic Instrument FamilyIntuitive Surgical, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
200110
200240
200440
200550
200630
200870
200930
201030
201180
201260
201380
2014120
201560
2016110
2017150
2018180
2019120
2020190
2021170
2022180
2023191
2024220
2025310
2026230
FIG. 1 — Lineage of K931340, 1993–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (277)

See all 277

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

NumberDeviceApplicantDecidedDescendants
K990144Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument…Intuitive Surgical, Inc.2000269
K991928Modular Laparoscopic Grasping Forceps, Scissors, Needle Holders & DissectorsAllegiance Healthcare Corp.19994
K113407Snowden Pencer Laparoscopic Ergonomic Reposable ScissorsCarefusion 2200, Inc.20121

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K223095Senhance Surgical SystemAsensus Surgical, Inc. · 2023 · 4 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K990144 (Intuitive Surgical, Inc., 2000) has gone furthest, with 269 descendants of its own.

How does its category compare?

All GCS devices

GCS Endoscope, Battery-Powered And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCS

FDA has decided no GCS device since 2007.

Median 510(k) review, days · GCS

Too few GCS 510(k)s in any year since 2007 to give a median.

Recalls per year · GCS

No recall names GCS since 2007.

Adverse event reports per year · GCS

No MAUDE report names GCS since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Baxter Healthcare Corp

590 FDA decisions under this applicant name. See the company

  • P990009/S077Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal…Baxter Healthcare Corp · 2025
  • P990009/S076Floseal Matrix/Floseal Matrix Hemostatic Sealant/Proceed Hemostatic SealantBaxter Healthcare Corp · 2025
  • P990009/S075Floseal Hemostatic MatrixBaxter Healthcare Corp · 2025
  • P050011/S009Adept Adhesion Reduction SolutionBaxter Healthcare Corp · 2024
  • P990009/S074Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast PrepBaxter Healthcare Corp · 2024

Recent decisions in GCS

The GCS category page

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  • K933371Imc Endoscopic Instrument HolderInman Medical Corp. · 1993

https://510kreport.com/device/K931340 · printed Nov 5, 2026

Cite this page

510(k) Report. “K931340: Grasp Forceps/Scissors/Needle Holder/Dissector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K931340

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026