510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K123811Substantially Equivalent

Stitchkit

ORIGAMI SURGICAL Inc., Dover MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123811 is the FDA 510(k) clearance record for STITCHKIT, a class II device, cleared for Origami Surgical, LLC on under FDA product code NBY (Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene). FDA records list 7 510(k) clearances for Origami Surgical, LLC, from to . As of , FDA records show no recalls naming K123811.

Clearance record

Decision date
Received
(268 days to decision)
Product code
NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Regulation
21 CFR 878.5035
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Origami Surgical, LLC 79 Haven St., Dover MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NBY

Trailing 12 months

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

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