510(k) Report

510(k) · Cleared

Cleared

Storz Model 62 Ent Camera System

K883760510(k) TraditionalCleared Sep 28, 198822-day reviewClass I21 CFR 878.4160

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

Storz Instrument Co. · FWL Camera, Cine, Endoscopic, Without Audio

Cleared on Sep 28, 1988 after a 22-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Sep 28, 1988
Review
22 days
Class
Class I
Product code
FWL
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K883760Source: 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.

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  • 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 FWL devices

FWL Camera, Cine, Endoscopic, Without Audio: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FWL

FDA has decided no FWL device since 2007.

Median 510(k) review, days · FWL

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

Recalls per year · FWL

No recall names FWL since 2007.

Adverse event reports per year · FWL

2in 2018

2016: 12018: 2
2007high 2 (2018) · low 0 (2007)2025

MAUDE reports naming product code FWL, 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—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—01
20170—00
20180—02
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
Cite this page

510(k) Report. “K883760: Storz Model 62 Ent Camera System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K883760

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