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

Scalp Cooling System

21 CFR 878.4360 / General, Plastic Surgery
FDA source (opens on fda.gov)

PMC is the FDA product code for Scalp Cooling System, a class II device type, regulated under 21 CFR 878.4360. FDA's definition for this code reads: "A scalp cooling system is intended to reduce or prevent the frequency and severity of alopecia during chemotherapy in which alopecia-inducing chemotherapeutic agents are used". As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
PMC
Device name
Scalp Cooling System
FDA definition
A scalp cooling system is intended to reduce or prevent the frequency and severity of alopecia during chemotherapy in which alopecia-inducing chemotherapeutic agents are used.
Regulation
21 CFR 878.4360
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
1

Clearances, product code PMC

By decision year
7 clearances under product code PMC with a decision year between 2015 and 2025, 2017 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PMC by decision year
YearClearances
20151
20172
20181
20191
20211
20251

Applicants with the most clearances

Product code PMC
Applicants holding the most 510(k) clearances under product code PMC
ApplicantClearances
Dignitana AB3
Paxman Coolers Limited2
Cooler Heads Care, Inc.1
Stemtech Medical Devices Private Limited1

Companies listing this code with FDA

Companies whose registered establishments list this code