510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K951897Substantially Equivalent

Power Resectoscope Cutting Loop

Power Analytics Corp., Sacramento CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K951897 is the FDA 510(k) clearance record for POWER RESECTOSCOPE CUTTING LOOP, a class II device, cleared for Power Analytics Corp. on under FDA product code FAS (Electrode, Electrosurgical, Active, Urological). FDA records list one 510(k) clearance for Power Analytics Corp. As of , FDA records show no recalls naming K951897.

Clearance record

Decision date
Received
(85 days to decision)
Product code
FAS Electrode, Electrosurgical, Active, Urological
Regulation
21 CFR 876.4300
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Power Analytics Corp. 819 Striker Ave., Suite 10, Sacramento CA
510(k) summary
Summary
Third party review
No

Clearances, product code FAS

Trailing 12 months
1 clearance under product code FAS in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FAS, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260