GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAG— 510(k) K132375

Name: FDA 510(k) clearance K132375
Creator: U.S. Food and Drug Administration
Published: 2014-06-12

Substantially Equivalent

Genicon

FDA 510(k) clearance K132375 for GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAG, Substantially Equivalent on 2014-06-12. Applicant: Genicon. Device class: 2.

Clearance details

Applicant: Genicon
Product code: Code GCJ
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2013-07-30
Decision date: 2014-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winter Park, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GCJ

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More clearances from Genicon

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K100090 — IMPLANTABLE CLIP2010-02-02
K061417 — GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-9102006-10-10
K041967 — GENICON SUCTION IRRIGATION SYSTEM2004-11-12
K041968 — GENICON BIPOLAR FORCEPS MODEL # 600-005-0052004-11-03

Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K132375

K-number listed on FDA's recall record

Z-1642-2015 — DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is a single-use specimen retrieval bag indicated for use in laparoscopic procedures to capture and remove organs or tissue from the body cavity.Class II·Terminated·DeRoyal Industries Inc·20150417

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132375.

Data sourced from openFDA. This site is unofficial and independent of the FDA.