Forceps, Biopsy, Bronchoscope (Rigid)
A Rigid Bronchoscope Biopsy Forceps is a surgical instrument used with rigid bronchoscopes to obtain tissue samples from the tracheobronchial tree for histopathological examination. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and compliance with general and special controls. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission. The product code is JEK, regulated under 21 CFR 874.4680, within the Ear, Nose, and Throat medical specialty.
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Basic Information
- Product Code
- JEK
- Device Class
- FDA class 2
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
Definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K990561 | OPTICAL FORCEPS | May 14, 1999 | Substantially Equivalent | Pilling Weck Surgical |
| K822198 | MALLEUS NIPPERS | Aug 25, 1982 | Substantially Equivalent | Kelleher Corp. |
| K822193 | FORCEPS FOR USE WITH RIGID ENDOSCOPES | Aug 24, 1982 | Substantially Equivalent | Kelleher Corp. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.