PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE)— 510(k) K962605

Substantially Equivalent

Surgicot, Inc.

FDA 510(k) clearance K962605 for PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE), Substantially Equivalent on 1997-03-11. Applicant: Surgicot, Inc..

Clearance details

Applicant: Surgicot, Inc.
Product code: Code FRG
Advisory panel: General Hospital
Date received: 1996-07-02
Decision date: 1997-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Research Triangle Park, NC, US

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Adverse events under product code FRG

product code FRG

Other: 3
Total: 3

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 →

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