510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K891001Substantially Equivalent

Microscope Knob Cover, Sterile, Disposable

Prescott's, Inc., Monument CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K891001 is the FDA 510(k) clearance record for MICROSCOPE KNOB COVER, STERILE, DISPOSABLE, a class I device, cleared for Prescott'S, Inc. on under FDA product code HRM (Microscope, Operating & Accessories, Ac-Powered, Ophthalmic). FDA records list 2 510(k) clearances for Prescott'S, Inc., from to . As of , FDA records show no recalls naming K891001.

Clearance record

Decision date
Received
(43 days to decision)
Product code
HRM Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
Regulation
21 CFR 878.4700
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Prescott'S, Inc. 2915 Vandenburg Ave., Monument CO
Third party review
No

Clearances, product code HRM

Trailing 12 months

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

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