FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
4 SURE TM ENEMA BAG SET
K Number: K922398
·
Decision Jun 17, 1993
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
29
Applicant Total
11
Review Days
392
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Basic Information
- Device Name
- 4 SURE TM ENEMA BAG SET
- K Number
- K922398
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5210
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Boston Pacific Medical, Inc.
- Date Received
- May 21, 1992
- Decision Date
- June 17, 1993
- Product Code
- FCE
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FCE | Enema Kit | FDA class 1 | Gastroenterology, Urology |
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Other Clearances by Boston Pacific Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K933109 | 4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS | Mar 28, 1994 | Unknown |
| K922402 | 4 SURE TM ENTERAL FEEDING BAG | Mar 25, 1994 | Substantially Equivalent |
| K931048 | 4-SURE NELATON CATHETER | Feb 14, 1994 | Substantially Equivalent |
| K931047 | 4-SURE FEMALE CATHETER | Feb 14, 1994 | Substantially Equivalent |
| K921852 | 4 SURE TM RECTAL TUBE | Oct 8, 1993 | Substantially Equivalent |
| K921853 | 4 SURE TM FEEDING TUBES | Jul 13, 1993 | Substantially Equivalent |
| K921851 | 4 SURE TM SUCTION CATHETERS & KITS | Jul 7, 1993 | Unknown |
| K922397 | 4 SURE TM NASAL OXYGEN CANNULA | Mar 18, 1993 | Substantially Equivalent |
| K924995 | 4 SURE TM ANESTHESIA EXTENSION SET | Dec 30, 1992 | Substantially Equivalent |
| K922401 | 4 SURE TM COLOSTOMY POUCH | Jun 10, 1992 | Substantially Equivalent |