Product Code: HGW
FDA class 2
21 CFR 884.1560
Sampler, Blood, Fetal
Obstetrics/Gynecology
The Fetal Blood Sampler is a device used to collect small blood specimens from the fetal scalp or other accessible fetal vessels during labor, allowing analysis of fetal blood pH and acid-base balance to assess fetal oxygenation status. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HGW, regulated under 21 CFR 884.1560, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.
510(k)s
4
FEI Numbers
0
Registration Numbers
0
Unique Applicants
2
Years Active
8
Research product code HGW in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- HGW
- Device Class
- FDA class 2
- Regulation Number
- 884.1560
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
Loading...
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K891388 | 1570 - FETAL BLOOD SAMPLING KIT | Mar 28, 1989 | Substantially Equivalent | Transidyne General Corp. |
| K884685 | ROCKET FETAL BLOOD SAMPLING TRAY | Jan 12, 1989 | Substantially Equivalent | A & A Medical, Inc. |
| K831459 | FETAL BLOOD SAMPLING KIT #1560 | Jun 30, 1983 | Substantially Equivalent | Transidyne General Corp. |
| K810028 | FETAL BLOOD SAMPLING KIT MODEL 1560 | Jan 16, 1981 | Substantially Equivalent | Transidyne General Corp. |