510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K875001Substantially Equivalent

Prisma Disposable Blunt Irrigating Cystotome

Advanced Surgical Products, Inc., Chesterfield MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K875001 is the FDA 510(k) clearance record for PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME, a class I device, cleared for Advanced Surgical Products, Inc. on under FDA product code HNY (Cystotome). FDA records list 64 510(k) clearances for Advanced Surgical Products, Inc., from to . As of , FDA records show no recalls naming K875001.

Clearance record

Decision date
Received
(131 days to decision)
Product code
HNY Cystotome
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Applicant
Advanced Surgical Products, Inc. 744 Goddard, Chesterfield MO
Third party review
No

Clearances, product code HNY

Trailing 12 months

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

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