510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911932Substantially Equivalent

J105 James Surgical System I/a Pack

O.R. Specialties, Inc., Tuscaloosa AL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911932 is the FDA 510(k) clearance record for J105 JAMES SURGICAL SYSTEM I/A PACK, a class I device, cleared for O.R. Specialties, Inc. on under FDA product code GZX (Instrument, Microsurgical). FDA records list 14 510(k) clearances for O.R. Specialties, Inc., from to . As of , FDA records show no recalls naming K911932.

Clearance record

Decision date
Received
(118 days to decision)
Product code
GZX Instrument, Microsurgical
Regulation
21 CFR 882.4525
Device class
Class I
Review panel
Neurology
Applicant
O.R. Specialties, Inc. 4749 Appletree Ln., Tuscaloosa AL
510(k) summary
Statement
Third party review
No

Clearances, product code GZX

Trailing 12 months

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

FDA records show no clearances under product code GZX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GZX, 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