510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863951Substantially Equivalent

P.s.i.-Disposable Scalpel Surgeons Handle

Precision Surgical Industries, Inc., Scotch Plains NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863951 is the FDA 510(k) clearance record for P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE, a class I device, cleared for Precision Surgical Industries, Inc. on under FDA product code GDZ (Handle, Scalpel). FDA records list 2 510(k) clearances for Precision Surgical Industries, Inc. As of , FDA records show no recalls naming K863951.

Clearance record

Decision date
Received
(14 days to decision)
Product code
GDZ Handle, Scalpel
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Precision Surgical Industries, Inc. 2507 Rte. 22 W, Scotch Plains NJ
Third party review
No

Clearances, product code GDZ

Trailing 12 months

FDA records hold no clearances under product code GDZ in the trailing twelve months.

FDA records show no clearances under product code GDZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GDZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260