FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNIMED DISPOSABLE HAND AND FOOT-SWITCHING PENCILS WITH HOLSTER AND 1BLADE AND TIP CLEANER, UNIMED DISPOSABLE HAND AND F
K Number: K993647
·
Decision Nov 16, 1999
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
13
Review Days
18
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
- UNIMED DISPOSABLE HAND AND FOOT-SWITCHING PENCILS WITH HOLSTER AND 1BLADE AND TIP CLEANER, UNIMED DISPOSABLE HAND AND F
- K Number
- K993647
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Unimed Surgical Products, Inc.
- Date Received
- October 29, 1999
- Decision Date
- November 16, 1999
- Product Code
- GEI
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEI), ordered by most recent decision date.
Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CoolSeal Generator® (CSL-200-90)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEUROMARK System (NMK00301)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LAP-iX2N
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MILAN System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Unimed Surgical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K132224 | UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES | Oct 8, 2013 | Substantially Equivalent |
| K970066 | UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE | Feb 18, 1997 | Substantially Equivalent |
| K963338 | UNIMED SUCTION-IRRIGATION ELECTRODE AND SLIDING SHEATH | Oct 21, 1996 | Substantially Equivalent |
| K962935 | UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE | Sep 3, 1996 | Substantially Equivalent |
| K944450 | SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE | Jul 25, 1995 | Substantially Equivalent |
| K944265 | NEEDLE ELCTRODE | May 5, 1995 | Substantially Equivalent |
| K946246 | SURGI-LINK BIPOLAR MICRO FORCEPS | Mar 7, 1995 | Substantially Equivalent |
| K945030 | SURGI-LINK LAPAROSCOPIC ELECTRODES | Nov 3, 1994 | Substantially Equivalent |
| K944898 | SURGI-LINK BIPOLAR ELECTRODES | Nov 1, 1994 | Substantially Equivalent |
| K944617 | SURGI-LINK DISPOSABLE PUSH BUTTON ESU PENCIL | Sep 29, 1994 | Substantially Equivalent |