FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TURKEL PNEUMOTHORAX KIT
K Number: K923028
·
Decision Aug 4, 1992
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
7
Applicant Total
34
Review Days
42
Basic Information
- Device Name
- TURKEL PNEUMOTHORAX KIT
- K Number
- K923028
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Symbiosis Corp.
- Date Received
- June 23, 1992
- Decision Date
- August 4, 1992
- Product Code
- GCB
- 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 |
|---|---|---|---|
| GCB | Needle, Catheter | FDA class 1 | General, Plastic Surgery |
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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 |