GYN DISPOSABLES TENACULUM 356T— 510(k) K073182
Substantially EquivalentGyn-Disposables, Inc.
FDA 510(k) clearance K073182 for GYN DISPOSABLES TENACULUM 356T, Substantially Equivalent on 2007-11-28. Applicant: Gyn-Disposables, Inc.. Device class: 2.
Clearance details
- Applicant
- Gyn-Disposables, Inc.
- Product code
- Code HDC
- Device class
- Class 2
- Regulation
- 21 CFR 884.4530
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Memphis, TN, US
Recent devices under product code HDC
view allRecalls naming K073182
K-number listed on FDA's recall record- Z-0126-2022 — Tenaculum, Plastic
- Z-0127-2022 — IUD Insertion Pack
- Z-0128-2022 — IUD Insertion Kit
- Z-0129-2022 — Endometrial Biopsy Kit
- Z-0130-2022 — Foundation Kit
- Z-0131-2022 — Standard IUD Insertion Kit
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K073182.
Data sourced from openFDA. This site is unofficial and independent of the FDA.