FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INSTAVAC II
K Number: K934976
·
Decision May 2, 1994
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
158
Applicant Total
5
Review Days
195
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- INSTAVAC II
- K Number
- K934976
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Aeros Instruments, Inc.
- Date Received
- October 19, 1993
- Decision Date
- May 2, 1994
- Product Code
- BTA
- 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 |
|---|---|---|---|
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BTA), ordered by most recent decision date.
Momcozy Nasal Aspirator (BN007)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Suction Pump (SU-90)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery