FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SKIN MARKER
K Number: K905143
·
Decision Feb 6, 1991
Classifications
1
FEI Numbers
183
Registration Numbers
184
Same Product Code
22
Applicant Total
207
Review Days
83
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SKIN MARKER
- K Number
- K905143
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4660
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Aesculap, Inc.
- Date Received
- November 15, 1990
- Decision Date
- February 6, 1991
- Product Code
- FZZ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FZZ | Marker, Skin | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FZZ), ordered by most recent decision date.
SURGICHIP TAG SURGICAL MARKER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DISPOSABLE SKIN MARKER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BLOOM TRANSPARENT STENCIL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ROCKET SURGICAL SKIN MARKING PEN
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
QUALTEX SKIN MARKER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SURGICAL SKIN MARKER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Aesculap, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K242762 | Aesculap Aicon® Series Container System | May 13, 2025 | Substantially Equivalent |
| K242003 | XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set | Dec 16, 2024 | Substantially Equivalent |
| K223596 | SQ.line KERRISON | Jun 29, 2023 | Substantially Equivalent |
| K214041 | Aesculap AICON Container | Dec 30, 2022 | Substantially Equivalent |
| K211572 | Aesculap Slim Clip Applier | Dec 13, 2021 | Substantially Equivalent |
| K203739 | ELAN 4 Electro Motor System | Aug 24, 2021 | Substantially Equivalent |
| K202391 | DIR 800 | Jan 21, 2021 | Substantially Equivalent |
| K203461 | Aesculap Caiman 12 Seal and Cut Technology System | Dec 18, 2020 | Substantially Equivalent |
| K202938 | Aesculap Caiman 5 Seal and Cut Technology System | Oct 30, 2020 | Substantially Equivalent |
| K202124 | Aesculap PAS-Port Proximal Anastomosis System | Sep 2, 2020 | Substantially Equivalent |