FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEXIDE BIPOLAR FORCEPS II** DEVICE
K Number: K993055
·
Decision Oct 5, 1999
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
218
Review Days
22
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Basic Information
- Device Name
- DEXIDE BIPOLAR FORCEPS II** DEVICE
- K Number
- K993055
- 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
- United States Surgical, A Division of Tyco Healthc
- Date Received
- September 13, 1999
- Decision Date
- October 5, 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 |
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|---|---|---|---|
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| K062850 | AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS | Oct 23, 2006 | Substantially Equivalent |
| K062326 | AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE | Sep 1, 2006 | Substantially Equivalent |
| K061095 | AUTO SUTUR ENDO GIA STAPLERS | May 31, 2006 | Substantially Equivalent |
| K050947 | MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE | Jun 1, 2005 | Substantially Equivalent |
| K042412 | MODIFIED SPACEMAKER SYSTEM | Sep 24, 2004 | Substantially Equivalent |
| K040594 | HERCULON SOFT TISSUE REATTACHMENT SYSTEM | Mar 31, 2004 | Substantially Equivalent |
| K032696 | AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT | Dec 1, 2003 | Substantially Equivalent |