DigniCap Delta— 510(k) K191166

Substantially Equivalent

Dignitana, Inc.

FDA 510(k) clearance K191166 for DigniCap Delta, Substantially Equivalent on 2019-06-26. Applicant: Dignitana, Inc.. Device class: 2.

Clearance details

Applicant: Dignitana, Inc.
Product code: Code PMC
Device class: Class 2
Regulation: 21 CFR 878.4360
Advisory panel: General, Plastic Surgery
Date received: 2019-05-01
Decision date: 2019-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PMC

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K173032 — Paxman Scalp Cooler2018-06-07
K170871 — DigniCap Scalp Cooling System2017-07-03
K163484 — Paxman Scalp Cooler2017-04-17

Recalls naming K191166

K-number listed on FDA's recall record

Z-0825-2022 — DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The DigniCap Scalp Cooling System User Manual (PN: 0P1DDCD01M-EN_C / IFU 20190325-06-EN), DigniCap Delta Scalp Cooling Wrap (LAB 20190221-05-EN), DigniCap Delta Small Cooling Wrap (LAB 20200616-01-EN, Quick Reference Guide DigniCap Delta (IFU-20190327-02-EN), The DigniCap Scalp Cooling System Training Guide- Global (TR-20200104-05-EN), The DigniCap Scalp Cooling System Training Guide TR-2019-0801-05-US, DigniCap Delta Procedural Expectations- Global (TR-20191028-03-EN), DigniCap Delta Procedural Expectations TR- 20190721-02-US, DigniCap Delta Small Wrap Protocol Global(TR-20200728-02-EN), DigniCap Delta Small Wrap Protocol TR-20200714-01-US, DigniCap Delta Training Tips Global (TR-20200420-04-EN), DigniCap Delta Training Tips TR-20191202-05-US,Class II·Terminated·Dignitana, Inc.·20211105

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K191166.

Data sourced from openFDA. This site is unofficial and independent of the FDA.