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SecurePortIV SP-015V

by Adhezion Biomedical, LLC 2 variants

SecurePortIV SP-015V is a wearable percutaneous catheter/tube holder (FDA Class II; FDA product code NZP, Sealant, Microbial) made by Adhezion Biomedical, LLC, cleared under FDA 510(k) K170505 on 29 Sep 2017 and listed in FDA GUDID since 30 Jan 2018 (UDI-DI M495SP015V1), 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) K170505

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 NumberM495SP015V1 UDI-DI Date30 Jan 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK170505 Date29 Sep 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K170505 decided 29 Sep 2017 Active
  • FDA GUDID UDI-DI M495SP015V1 listed 30 Jan 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K170505
  2. Listed FDA GUDID M495SP015V1

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SecurePortIV
Generic name
Wearable percutaneous catheter/tube holder, single-use
Model / Ref / Catalog
SP-015V
Primary DI / UDI-DI
M495SP015V1
510(k) Number
FDA product code
NZP
GMDN term
Wearable percutaneous catheter/tube holder, single-use
Device class
Class II
Regulation number
878.4370
GUDID distribution status
In Commercial Distribution
Size
Total Volume — .15 Milliliter

Related devices

Category: Wearable percutaneous catheter/tube holder

Cleared under the same submission (K170505)

Similar devices in this category

Other devices filed under Wearable percutaneous catheter/tube holder.

Other devices from Adhezion Biomedical, LLC

See all devices from Adhezion Biomedical, LLC →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)