KEISEI HANDLES FOR SURGICAL BLADES— 510(k) K863212

Name: FDA 510(k) clearance K863212
Creator: U.S. Food and Drug Administration
Published: 1986-09-02

Substantially Equivalent

Keisei Medical Industrial Co., Ltd.

FDA 510(k) clearance K863212 for KEISEI HANDLES FOR SURGICAL BLADES, Substantially Equivalent on 1986-09-02. Applicant: Keisei Medical Industrial Co., Ltd.. Device class: 1.

Clearance details

Applicant: Keisei Medical Industrial Co., Ltd.
Product code: Code GDZ
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1986-08-20
Decision date: 1986-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethel, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GDZ

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K091462 — SPECTRA MEDICAL SAFETY SCAPEL2009-12-15
K890242 — SCALPEL HANDLE1989-01-27
K884512 — BEAVER(R) HANDLE1988-11-17
K863951 — P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE1986-10-24
K863808 — THE S. CORDERO STYLUS1986-10-14

More clearances from Keisei Medical Industrial Co., Ltd.

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K863211 — KEISEI SURGICAL BLADES (STERILE & NON-STERILE)1986-09-02
K863213 — KEISEI SCALPEL (STERILE AND NON-STERILE)1986-09-02
K863214 — KEISEI MICRO-BLADES (STERILE AND NON-STERILE)1986-09-02

Adverse events under product code GDZ

product code GDZ

Other: 1
Total: 1

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.