FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE
K Number: K922100
·
Decision Mar 15, 1993
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
73
Applicant Total
9
Review Days
315
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
- DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE
- K Number
- K922100
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Graham Medical Products
- Date Received
- May 4, 1992
- Decision Date
- March 15, 1993
- Product Code
- EJJ
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| EJJ | Alloy, Amalgam | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EJJ), ordered by most recent decision date.
SILVERFIL
FDA 510(k)
FDA Class 2
·Dental
SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70
FDA 510(k)
FDA Class 2
·Dental
BESTALOY
FDA 510(k)
FDA Class 2
·Dental
BENCO ADMIX
FDA 510(k)
FDA Class 2
·Dental
BENCO SPHERICAL
FDA 510(k)
FDA Class 2
·Dental
HIGH SILVER CONVENTIONAL
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Graham Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K921657 | VASECTOMY DRAPE | Mar 18, 1993 | Substantially Equivalent |
| K922059 | DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #599 | Mar 3, 1993 | Substantially Equivalent |
| K913447 | DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #599 | Feb 7, 1992 | Substantially Equivalent |
| K913448 | DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE | Feb 7, 1992 | Substantially Equivalent |
| K913560 | STOPCOCK | Dec 31, 1991 | Substantially Equivalent |
| K903726 | DRAPE, SURGICAL - UTILITY DRAPE - STERILE | Aug 27, 1990 | Substantially Equivalent |
| K863981 | STERILIZATION WRAPS #620,624,648,640,636,630,612 | Nov 25, 1986 | Substantially Equivalent |
| K864111 | STERILE FIELD #605 FENESTRATED STERILE FIELD #606 | Oct 30, 1986 | Substantially Equivalent |