FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MANAN BLUNT NEEDLE
K Number: K981386
·
Decision Jun 29, 1998
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
39
Review Days
74
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
- MANAN BLUNT NEEDLE
- K Number
- K981386
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Manan Medical Products, Inc.
- Date Received
- April 16, 1998
- Decision Date
- June 29, 1998
- Product Code
- FPA
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FPA), ordered by most recent decision date.
iiSure Infusion Set
FDA 510(k)
FDA Class 2
·General Hospital
AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)
FDA 510(k)
FDA Class 2
·General Hospital
PuraCath Firefly Needleless Connector IT (9005)
FDA 510(k)
FDA Class 2
·General Hospital
nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]
FDA 510(k)
FDA Class 2
·General Hospital
BD Alaris Pump Infusion Set
FDA 510(k)
FDA Class 2
·General Hospital
EZ IV Administration Set
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Manan Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K052802 | MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE | Nov 1, 2005 | Substantially Equivalent |
| K011209 | MANAN SPRITACRE SPINAL NEEDLES | Jun 26, 2001 | Substantially Equivalent |
| K983620 | MANAN SPINAL NEEDLES | Jan 8, 1999 | Substantially Equivalent |
| K980536 | EPIDURAL NEEDLE | Jul 31, 1998 | Substantially Equivalent |
| K980211 | MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES | Feb 6, 1998 | Substantially Equivalent |
| K974446 | MANAN AUTOMATIC CUTTING NEEDLE | Jan 8, 1998 | Substantially Equivalent |
| K962977 | MRI COMPATIBLE BIOPSY NEEDLES | Oct 9, 1997 | Substantially Equivalent |
| K963767 | MANAN V.S. ACCESS NEEDLE/SET | May 16, 1997 | Substantially Equivalent |
| K961986 | MANAN D BAG | Mar 13, 1997 | Substantially Equivalent |
| K962001 | MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE | Jan 10, 1997 | Substantially Equivalent |