510(k) Report

510(k) · Cleared

Cleared

Disposable External Clamps

K896383510(k) TraditionalCleared Dec 6, 198930-day reviewClass I21 CFR 878.4800

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

Galenica Enterprises, Inc. · GDI Dissector, Surgical, General & Plastic Surgery

Cleared on Dec 6, 1989 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 6, 1989
Review
30 days
Class
Class I
Product code
GDI
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K896383Source: 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 GDI? 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?

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 GDI devices

GDI Dissector, Surgical, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GDI

FDA has decided no GDI device since 2007.

Median 510(k) review, days · GDI

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

Recalls per year · GDI

2in 2011

2007: 12008: 12010: 12011: 2
2007high 2 (2011) · low 0 (2009)2026

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

Adverse event reports per year · GDI

13in 2025

2007: 552008: 452009: 212010: 82011: 42012: 72013: 42014: 22015: 72016: 52017: 72018: 22019: 22020: 42023: 62024: 202025: 13
2007high 55 (2007) · low 0 (2021)2025

MAUDE reports naming product code GDI, 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—155
20080—145
20090—021
20100—18
20110—24
20120—07
20130—04
20140—02
20150—07
20160—05
20170—07
20180—02
20190—02
20200—04
20210—00
20220—00
20230—06
20240—020
20250—013
20260—0—

More from Galenica Enterprises, Inc.

5 FDA decisions under this applicant name. See the company

  • K923656Lighting Source SystemGalenica Enterprises, Inc. · 1994
  • K883283Disposable AmniotomeGalenica Enterprises, Inc. · 1988
  • K861017Galenica's Disposable AnoscopesGalenica Enterprises, Inc. · 1986
  • K841909Vaginal Speculum - DisposableGalenica Enterprises, Inc. · 19841 recall

Recent decisions in GDI

The GDI category page

  • K850288Hepatic Parenchymal Suction DissectorBeecher Medical Diagnostic Instrumentation · 1985
  • K831912Round-Beehive- Dissectors 3/8Ormed Mfg., Inc. · 1983
  • K822569Tympanoplasty & Skin DissectorsKelleher Corp. · 1982
  • K803292Field Suction DissectorV. Mueller O.V. Baxter Healthcare Corp. · 1981
  • K791870Disposable Speciality SpongesCarwild Corp. · 1979

https://510kreport.com/device/K896383 · printed Nov 4, 2026

Cite this page

510(k) Report. “K896383: Disposable External Clamps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K896383

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