510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K233670Substantially Equivalent

Ascension Silicone MCP; Ascension Silicone PIP

Ascension Orthopedics, Inc., Austin TX / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K233670 is the FDA 510(k) clearance record for Ascension Silicone MCP; Ascension Silicone PIP, a class II device, cleared for Ascension Orthopedics, Inc. on under FDA product code KYJ (Prosthesis, Finger, Constrained, Polymer). FDA records list 29 510(k) clearances for Ascension Orthopedics, Inc., from to . As of , FDA records show no recalls naming K233670.

Clearance record

Decision date
Received
(29 days to decision)
Product code
KYJ Prosthesis, Finger, Constrained, Polymer
Regulation
21 CFR 888.3230
Device class
Class II
Review panel
Orthopedic
Applicant
Ascension Orthopedics, Inc. 11101 Metric Blvd., Austin TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KYJ

Trailing 12 months

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

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