510(K) CLEARANCES 63 ▲12RECALLS POSTED 17 ▼8CLASS I 1PMA DECISIONS 48 ▼2WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K991256Substantially Equivalent

Viewpoint Ent/orthopedic Option

Philips North America LLC, Cleveland OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991256 is the FDA 510(k) clearance record for VIEWPOINT ENT/ORTHOPEDIC OPTION, a class II device, cleared for Philips Medical Systems (Cleveland), Inc. on under FDA product code HAW (Neurological Stereotaxic Instrument). FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show no recalls naming K991256.

Clearance record

Decision date
Received
(178 days to decision)
Product code
HAW Neurological Stereotaxic Instrument
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Applicant
Philips Medical Systems (Cleveland), Inc. 595 Miner Rd., Cleveland OH
510(k) summary
Summary
Third party review
No

Clearances, product code HAW

Trailing 12 months
6 clearances under product code HAW in the twelve months to November 2026, October 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code HAW, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20261
September 20261
October 20262
November 20260