FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
4 SURE TM RECTAL TUBE
K Number: K921852
·
Decision Oct 8, 1993
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
4
Applicant Total
11
Review Days
539
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Basic Information
- Device Name
- 4 SURE TM RECTAL TUBE
- K Number
- K921852
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5160
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Boston Pacific Medical, Inc.
- Date Received
- April 17, 1992
- Decision Date
- October 8, 1993
- Product Code
- KMO
- 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 |
|---|---|---|---|
| KMO | Binder, Elastic | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KMO), ordered by most recent decision date.
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STERILIZATION PROCESS/T-BINDER
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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 |
| K921853 | 4 SURE TM FEEDING TUBES | Jul 13, 1993 | Substantially Equivalent |
| K921851 | 4 SURE TM SUCTION CATHETERS & KITS | Jul 7, 1993 | Unknown |
| K922398 | 4 SURE TM ENEMA BAG SET | Jun 17, 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 |