Home / 510(k) Clearances / K193383

510(k) K193383

SnugKap by Headstart, Ltd. — Product Code MVA

K193383 is an FDA 510(k) premarket notification submitted by Headstart, Ltd. for the device "SnugKap". The FDA issued a decision of Substantially Equivalent on June 7, 2021. The device falls under product code MVA (Orthosis, Cranial), a Class II device regulated under 21 CFR 882.5970.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2021
Date Received
December 5, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Cranial
Device Class
Class II
Regulation Number
882.5970
Review Panel
NE
Submission Type

Other clearances for product code MVA

  • K241957 — Talee, Talee PostOp (August 30, 2024)
  • K230444 — Talee, Talee PostOp (June 22, 2023)
  • K223238 — STARband 3D (April 20, 2023)
  • K220681 — Talee, Talee PostOP (September 22, 2022)
  • K203134 — Hanger Cranial Band 3D (July 1, 2022)
  • K213587 — MyCRO Band (June 9, 2022)
  • K201426 — MyCRO Band (March 26, 2021)
  • K180568 — KidCap (October 16, 2018)
  • K141842 — STARBAND, STARLIGHT (October 6, 2014)
  • K140353 — STARBAND AND STARLIGHT (June 6, 2014)

FDA data resources