FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HARMONIC SCALPEL LAPAROSONIC CLAMP COAGULATOR ACC.
K Number: K925699
·
Decision May 17, 1993
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
9
Review Days
186
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Basic Information
- Device Name
- HARMONIC SCALPEL LAPAROSONIC CLAMP COAGULATOR ACC.
- K Number
- K925699
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ultracision, Inc.
- Date Received
- November 12, 1992
- Decision Date
- May 17, 1993
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Ultracision, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K952726 | ULTRACISION HARMONIC SCAPEL | Jun 23, 1995 | Substantially Equivalent |
| K941897 | ULTRACISON HARMONIC SCALPEL HS2 BLADE | Jul 1, 1994 | Substantially Equivalent |
| K930352 | HARMONIC SCALPEL REUSABLE LAPORASCOPIC BLADE SYST. | Jun 8, 1993 | Substantially Equivalent |
| K924917 | HARMONIC SCALPEL 5MM LAPAROSONIC BLADE ACCESSORY | May 21, 1993 | Substantially Equivalent |
| K924281 | HARMONIC SCALPEL LAPAROSONIC BLADE ACCESSORY | Apr 23, 1993 | Substantially Equivalent |
| K911341 | HARMONIC SCALPEL ENDOSCOPIC BLADE COUPLER EXTENSIO | Jun 24, 1991 | Substantially Equivalent |
| K905315 | ULTRACISION HARMONIC SCALPEL | Feb 15, 1991 | Substantially Equivalent |
| K895252 | ULTRACISION ULTRASONIC SCALPEL | Oct 31, 1989 | Substantially Equivalent |