510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K851203Substantially Equivalent

R Pak

CooperVision, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851203 is the FDA 510(k) clearance record for R PAK, cleared for CooperVision, Inc. on under FDA product code LFL (Instrument, Ultrasonic Surgical). FDA records list 97 510(k) clearances for CooperVision, Inc., from to . As of , FDA records show no recalls naming K851203.

Clearance record

Decision date
Received
(119 days to decision)
Product code
LFL Instrument, Ultrasonic Surgical
Device class
Unclassified
Review panel
Unknown
Applicant
CooperVision, Inc. 17701 Cowan Ave.P. O. Box, Irvine CA
Third party review
No

Clearances, product code LFL

Trailing 12 months
2 clearances under product code LFL in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LFL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20261