Skip to content

Arrow IPN034182

by Teleflex Incorporated

Arrow IPN034182 (ASK-01601-MM) is a Class I device made by Teleflex Incorporated, cleared under FDA 510(k) K895516 on 27 Dec 1989 and listed in FDA GUDID since 30 Sep 2016 (UDI-DI 10801902125702), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K895516

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10801902125702 UDI-DI Date30 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK895516 Date27 Dec 1989DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K895516 decided 27 Dec 1989 Active
  • FDA GUDID UDI-DI 10801902125702 listed 30 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K895516
  2. Listed FDA GUDID 10801902125702

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Arrow
Generic name
Incision/drainage kit
Model / Ref / Catalog
IPN034182, ASK-01601-MM
Primary DI / UDI-DI
10801902125702
510(k) Number
FDA product code
GBX
GMDN term
Incision/drainage kit
Device class
Class I
Regulation number
878.4200
GUDID distribution status
In Commercial Distribution

Related devices

Category: Incision/drainage kit

Cleared under the same submission (K895516)

and 8 more cleared under K895516

Similar devices in this category

Other devices filed under Incision/drainage kit.

Other devices from Teleflex Incorporated

  • Arrow IPNB00820 Open recall

    Class II

  • Arrow IPNB00826 Open recall

    Class II

  • Arrow IPNB00822 Open recall

    Class II

  • Arrow IPNB00827 Open recall

    Class II

See all devices from Teleflex Incorporated →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Combination product
  • Lot / batch number
  • Expiration date
Other properties (8, all answered No)