FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPTICAL FORCEPS
K Number: K990561
·
Decision May 14, 1999
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
2
Applicant Total
5
Review Days
81
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Basic Information
- Device Name
- OPTICAL FORCEPS
- K Number
- K990561
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pilling Weck Surgical
- Date Received
- February 22, 1999
- Decision Date
- May 14, 1999
- Product Code
- JEK
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| JEK | Forceps, Biopsy, Bronchoscope (Rigid) | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JEK), ordered by most recent decision date.
MALLEUS NIPPERS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
FORCEPS FOR USE WITH RIGID ENDOSCOPES
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Pilling Weck Surgical
| K Number | Device Name | ||
|---|---|---|---|
| K992476 | PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS | Sep 13, 2000 | Substantially Equivalent |
| K992174 | PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP | Mar 23, 2000 | Substantially Equivalent |
| K990935 | JACKSON ESOPHAGEAL DILATOR | May 17, 1999 | Substantially Equivalent |
| K982128 | SHIKANI-FRENCH SPEAKING VALVE | Oct 23, 1998 | Substantially Equivalent |