510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800669Substantially Equivalent

Feldman Mini-Saw, #300000

Karl Storz Endoscopy-America, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800669 is the FDA 510(k) clearance record for FELDMAN MINI-SAW, #300000, a class I device, cleared for KARL STORZ Endoscopy-America, Inc. on under FDA product code EWQ (Saw, Surgical, Ent (Electric Or Pneumatic)). FDA records list 402 510(k) clearances for KARL STORZ Endoscopy-America, Inc., from to . As of , FDA records show no recalls naming K800669.

Clearance record

Decision date
Received
(26 days to decision)
Product code
EWQ Saw, Surgical, Ent (Electric Or Pneumatic)
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
KARL STORZ Endoscopy-America, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EWQ

Trailing 12 months

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

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