510(k) Report

510(k) · Cleared

Recalled · 2004

Visecera Retainer

K802806510(k) TraditionalCleared Jan 23, 198177-day reviewClass I21 CFR 878.4800Recalls 1

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

Adept-Med Intl., Inc. · GCZ Retainer, Surgical

Cleared on Jan 23, 1981 after a 77-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled once.

Decided
Jan 23, 1981
Review
77 days
Class
Class I
Product code
GCZ
Recalls
1
Predicates
0

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

FIG. 1 — Lineage of K802806Source: 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 GCZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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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)

Recalls of this device

DateClassRecallRoot causeReason
Aug 17, 2004Not classifiedZ-1156-06OtherDevices for which sterility may be compromised as evidenced by a loss of package integrity.

No ancestor or descendant has a Class I recall.

How does its category compare?

All GCZ devices

GCZ Retainer, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCZ

FDA has decided no GCZ device since 2007.

Median 510(k) review, days · GCZ

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

Recalls per year · GCZ

No recall names GCZ since 2007.

Adverse event reports per year · GCZ

1in 2025

2009: 12014: 12015: 32016: 32017: 82018: 82024: 12025: 1
2007high 8 (2017) · low 0 (2007)2025

MAUDE reports naming product code GCZ, 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—01
20100—00
20110—00
20120—00
20130—00
20140—01
20150—03
20160—03
20170—08
20180—08
20190—00
20200—00
20210—00
20220—00
20230—00
20240—01
20250—01
20260—0—

More from Adept-Med Intl., Inc.

6 FDA decisions under this applicant name. See the company

  • K935636GravespecAdept-Med Intl., Inc. · 1994
  • K893871Goott Balfour BladeAdept-Med Intl., Inc. · 1989
  • K893869Goott Multipurpose Flexible Retractor (Sterile)Adept-Med Intl., Inc. · 1989
  • K893870Adams Breast Implant ProtectorAdept-Med Intl., Inc. · 1989
  • K870809Mcnealy-Glassman Viscera Retainer #3202/3204/3206Adept-Med Intl., Inc. · 19871 recall

Recent decisions in GCZ

The GCZ category page

  • K904536Jain Graft AssistJain Surgical Equipment, Inc. · 1990
  • K893870Adams Breast Implant ProtectorAdept-Med Intl., Inc. · 1989
  • K870809Mcnealy-Glassman Viscera Retainer #3202/3204/3206Adept-Med Intl., Inc. · 19871 recall
  • K801610Children's Hospital Pediatric RetractorEdward Weck, Inc. · 1980

https://510kreport.com/device/K802806 · printed Nov 4, 2026

Cite this page

510(k) Report. “K802806: Visecera Retainer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K802806

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