FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REPROCESSED HAND ACTIVATE SEALER/DIVIDER
K Number: K111600
·
Decision Nov 15, 2011
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
36
Applicant Total
21
Review Days
160
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Basic Information
- Device Name
- REPROCESSED HAND ACTIVATE SEALER/DIVIDER
- K Number
- K111600
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ascent Healthcare Solutions
- Date Received
- June 8, 2011
- Decision Date
- November 15, 2011
- Product Code
- NUJ
- 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 |
|---|---|---|---|
| NUJ | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Ascent Healthcare Solutions
| K Number | Device Name | ||
|---|---|---|---|
| K110189 | REPROCESSED ELECTROSURGICAL INSTRUMENT | Jul 18, 2011 | Substantially Equivalent |
| K100909 | REPROCESSED COMPRESSION SLEEVES | Jul 23, 2010 | Substantially Equivalent |
| K100254 | REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER | May 28, 2010 | Substantially Equivalent |
| K100537 | REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE | May 12, 2010 | Substantially Equivalent |
| K100080 | REPROCESSED TROCARS, MODEL B5LT AND CB5LT | Mar 19, 2010 | Substantially Equivalent |
| K093702 | REPROCESSED ULTRASONIC COAGULATING SHEARS | Mar 4, 2010 | Substantially Equivalent |
| K092425 | REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10 | Oct 21, 2009 | Substantially Equivalent |
| K090323 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | Apr 1, 2009 | Substantially Equivalent |
| K082023 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | Sep 16, 2008 | Substantially Equivalent |
| K081238 | REPROCESSED MASIMO PULSE OXIMETER SENSORS | Jul 29, 2008 | Substantially Equivalent |