Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K910889Substantially Equivalent

Abc Laparoscopic Handprobe

Birtcher Medical Systems, Inc., San Jose CA / Traditional, Substantially Equivalent

K910889 is the FDA 510(k) clearance record for ABC LAPAROSCOPIC HANDPROBE, a class II device, cleared for Birtcher Medical Systems, Inc. on under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories). FDA's definition for product code GEI reads: "Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available...". FDA records list 13 510(k) clearances for Birtcher Medical Systems, Inc., from to . As of , FDA records show no recalls naming K910889.

Clearance record

Decision date
Received
(178 days to decision)
Product code
GEI Electrosurgical, Cutting & Coagulation & Accessories
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Birtcher Medical Systems, Inc. 6110 Bollinger Rd., San Jose CA
Third party review
No

Clearances, product code GEI

Trailing 12 months
47 clearances under product code GEI in the twelve months to October 2026, June 2026 the highest month at 9.
Show the numbers
Monthly 510(k) clearances under FDA product code GEI, trailing twelve months
MonthClearances
November 20254
December 20251
January 20266
February 20263
March 20265
April 20265
May 20264
June 20269
July 20263
August 20262
September 20265
October 20260