510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921244Substantially Equivalent

Disposable Protective Sheath

Cogentix Medical, Inc., Natick MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921244 is the FDA 510(k) clearance record for DISPOSABLE PROTECTIVE SHEATH, a class II device, cleared for Vision-Sciences, Inc. on under FDA product code EOB (Nasopharyngoscope (Flexible Or Rigid)). FDA's definition for product code EOB reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". FDA records list 35 510(k) clearances for COGENTIX MEDICAL, INC., from to . As of , FDA records show no recalls naming K921244.

Clearance record

Decision date
Received
(204 days to decision)
Product code
EOB Nasopharyngoscope (Flexible Or Rigid)
Regulation
21 CFR 874.4760
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Vision-Sciences, Inc. 6 Strathmore Rd., Natick MA
510(k) summary
Statement
Third party review
No

Clearances, product code EOB

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