FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOPSY NEEDLE GUIDE ATTACHMENT
K Number: K863797
·
Decision Mar 27, 1987
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
35
Applicant Total
94
Review Days
179
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
- BIOPSY NEEDLE GUIDE ATTACHMENT
- K Number
- K863797
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2960
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Elscint, Inc.
- Date Received
- September 29, 1986
- Decision Date
- March 27, 1987
- Product Code
- HGL
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HGL | Transducer, Ultrasonic, Obstetric | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HGL), ordered by most recent decision date.
ULTRASOUND TRANSDUCER, MODEL US917
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OP3/VP4
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ULTRASONIC PULSED DOPPLER IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Elscint, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K983313 | ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY | Dec 11, 1998 | Substantially Equivalent |
| K982060 | VOLUMAX CT IMAGING SYSTEM | Sep 2, 1998 | Substantially Equivalent |
| K974344 | CT SCOPE | Jun 3, 1998 | Substantially Equivalent |
| K980306 | GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP | Apr 2, 1998 | Substantially Equivalent |
| K974614 | GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102 | Mar 4, 1998 | Substantially Equivalent |
| K972592 | 2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101) | Sep 15, 1997 | Substantially Equivalent |
| K970680 | GLORY | Jun 20, 1997 | Substantially Equivalent |
| K965044 | GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102 | Jun 16, 1997 | Substantially Equivalent |
| K970980 | CARDIAC SCORING FOR CT SCANNERS | May 29, 1997 | Substantially Equivalent |
| K970005 | GYREX 2T-PRESTIGE | Mar 28, 1997 | Substantially Equivalent |