510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K170003Substantially Equivalent

Zip 4 Skin Closure Device

Zipline Medical, Inc., Campbell CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K170003 is the FDA 510(k) clearance record for Zip 4 Skin Closure Device, a class I device, cleared for Zipline Medical, Inc. on under FDA product code PYO (Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use). FDA's definition for product code PYO reads: "A device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect...". FDA records list one 510(k) clearance for Zipline Medical, Inc. As of , FDA records show no recalls naming K170003.

Clearance record

Decision date
Received
(227 days to decision)
Product code
PYO Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use
Regulation
21 CFR 880.5240
Device class
Class I
Review panel
General Hospital
Applicant
Zipline Medical, Inc. 747 Camden Ave., Campbell CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PYO

Trailing 12 months

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

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