510(k) Report

510(k) · Cleared

Cleared

Grasping Forceps

K933261510(k) TraditionalCleared Jan 11, 1994189-day reviewClass II21 CFR 876.4680

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

Surgitek · FGO Dislodger, Stone, Flexible

Cleared on Jan 11, 1994 after a 189-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Jan 11, 1994
Review
189 days
Class
Class II
Product code
FGO
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K933261Source: FDA 510(k) database · 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.

Planning a device in FGO? 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All FGO devices

FGO Dislodger, Stone, Flexible: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FGO

FDA has decided no FGO device since 2007.

Median 510(k) review, days · FGO

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

Recalls per year · FGO

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FGO

10in 2025

2007: 22008: 232009: 322010: 112011: 152012: 132013: 152014: 42015: 152016: 212017: 172018: 142019: 252020: 192021: 142022: 182023: 142024: 192025: 10
2007high 32 (2009) · low 2 (2007)2025

MAUDE reports naming product code FGO, 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
20070—02
20080—023
20090—032
20100—011
20110—115
20120—013
20130—015
20140—04
20150—015
20160—021
20170—017
20180—014
20190—025
20200—019
20210—014
20220—018
20230—014
20240—019
20250—010
20260—0—

More from Surgitek

29 FDA decisions under this applicant name. See the company

  • K946296Quadra-Coil Ureteral StentSurgitek · 1995
  • K944391OM-4 (Tenative) Urodynamic Measruement SystemSurgitek · 1995
  • K943491Right Angle Urologic Laser FiberSurgitek · 1994
  • K941952Surgitek InfuserSurgitek · 1994
  • K933260Helical Stone/Flatwire Stone BasketsSurgitek · 1994

Recent decisions in FGO

The FGO category page

  • K001563Scipro (TM) Flexible Stone Dislodger and Retrieval SetScion Cardiovascular, Inc. · 20002 recalls
  • K970121Stone Dislodger, BasketBoston Scientific Corp · 1997
  • K963750Retrieval SnareBoston Scientific Corp · 1996
  • K962676Disposable Endoscopic Retrieval DeviceUnited States Endoscopy Group, Inc. · 19962 recalls
  • K951309Stone Dislodger, BasketBoston Scientific Corp · 1995

https://510kreport.com/device/K933261 · printed Nov 4, 2026

Cite this page

510(k) Report. “K933261: Grasping Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K933261

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