510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K191166Substantially Equivalent

DigniCap Delta

Dignitana AB, Dallas TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191166 is the FDA 510(k) clearance record for DigniCap Delta, a class II device, cleared for Dignitana, Inc. on under FDA product code PMC (Scalp Cooling System). FDA's definition for product code PMC 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". FDA records list 3 510(k) clearances for Dignitana, Inc., from to . As of , FDA records show one recall naming K191166.

Clearance record

Decision date
Received
(56 days to decision)
Product code
PMC Scalp Cooling System
Regulation
21 CFR 878.4360
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Dignitana, Inc. 10925 Estate Ln., Suite W-185, Dallas TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PMC

Trailing 12 months
1 clearance under product code PMC in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PMC, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260