510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K040763Substantially Equivalent

Resect Medical Inline Bi-Polar RF Linear Coagulation Device

Resect Medical, Inc., Fremont CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040763 is the FDA 510(k) clearance record for RESECT MEDICAL INLINE BI-POLAR RF LINEAR COAGULATION DEVICE, a class II device, cleared for Resect Medical, 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 one 510(k) clearance for Resect Medical, Inc. As of , FDA records show no recalls naming K040763.

Clearance record

Decision date
Received
(14 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
Resect Medical, Inc. 40874 Calido Pl., Fremont CA
510(k) summary
Summary PDF
Third party review
Yes

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