FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE SUCTION PROBE
K Number: K942061
·
Decision May 16, 1994
Classifications
1
FEI Numbers
331
Registration Numbers
331
Same Product Code
83
Applicant Total
218
Review Days
17
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 SUCTION PROBE
- K Number
- K942061
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- United States Surgical, A Division of Tyco Healthc
- Date Received
- April 29, 1994
- Decision Date
- May 16, 1994
- Product Code
- JOL
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| JOL | Catheter And Tip, Suction | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JOL), ordered by most recent decision date.
STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014
FDA 510(k)
FDA Class 2
·General Hospital
PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION
FDA 510(k)
FDA Class 2
·General Hospital
PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION
FDA 510(k)
FDA Class 2
·General Hospital
WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION
FDA 510(k)
FDA Class 2
·General Hospital
STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP
FDA 510(k)
FDA Class 2
·General Hospital
HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by United States Surgical, A Division of Tyco Healthc
| K Number | Device Name | ||
|---|---|---|---|
| K071406 | AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER | Nov 21, 2007 | Substantially Equivalent |
| K071920 | AUTOSUTURE ABSORBABLE TACK AND APPLICATOR | Sep 28, 2007 | Substantially Equivalent |
| K061288 | AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER | Nov 2, 2006 | Substantially Equivalent |
| K062850 | AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS | Oct 23, 2006 | Substantially Equivalent |
| K062326 | AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE | Sep 1, 2006 | Substantially Equivalent |
| K061095 | AUTO SUTUR ENDO GIA STAPLERS | May 31, 2006 | Substantially Equivalent |
| K050947 | MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE | Jun 1, 2005 | Substantially Equivalent |
| K042412 | MODIFIED SPACEMAKER SYSTEM | Sep 24, 2004 | Substantially Equivalent |
| K040594 | HERCULON SOFT TISSUE REATTACHMENT SYSTEM | Mar 31, 2004 | Substantially Equivalent |
| K032696 | AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT | Dec 1, 2003 | Substantially Equivalent |