FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOPATH VERESS NEEDLE
K Number: K910855
·
Decision Apr 18, 1991
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
1
Applicant Total
34
Review Days
49
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Basic Information
- Device Name
- ENDOPATH VERESS NEEDLE
- K Number
- K910855
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Symbiosis Corp.
- Date Received
- February 28, 1991
- Decision Date
- April 18, 1991
- Product Code
- FHP
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FHP | Needle, Pneumoperitoneum, Simple | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FHP), ordered by most recent decision date.
MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Symbiosis Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K955119 | SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES | Jan 18, 1996 | Substantially Equivalent |
| K953453 | SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES | Jan 17, 1996 | Substantially Equivalent |
| K953242 | SYMBIOSIS MONOPLAR ELECTROSURGICAL ELECTRODES | Oct 6, 1995 | Substantially Equivalent |
| K952432 | SYMBIOSIS BIPOLAR FORCEPS | Jul 5, 1995 | Substantially Equivalent |
| K951387 | SYMBIOSIS BIPOLAR SCISSORS | Apr 10, 1995 | Substantially Equivalent |
| K950286 | SYMBIOSIS BIPOLAR SCISSORS | Feb 3, 1995 | Substantially Equivalent |
| K946238 | SYMBIOSIS GASTROINTESTINAL BIOPSY FORCEPS | Jan 20, 1995 | Substantially Equivalent |
| K930773 | SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPS | Jul 28, 1994 | Substantially Equivalent |
| K941426 | SYMBIOSIS REUSABLE MONOPOLAR ELECTROSURGICAL PROBE | Jun 22, 1994 | Substantially Equivalent |
| K932266 | SYMBIOSIS DISPOS GASTRO BIOPSY FORCEPS W/REUSE HAN | Mar 15, 1994 | Substantially Equivalent |