Laparoscopic/Endoscopic Instruement
FDA 510(k) K943989 · Gabris Surgical Corp.
510(k) numberK943989
Submission
- Device name
- Laparoscopic/Endoscopic Instruement
- Applicant
- Gabris Surgical Corp.
Virginia Beach, VA, US - Received
- August 16, 1994
- Decision date
- September 12, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HFO – Recorder, Pressure, Intrauterine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2700
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HFO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K973850 | Alexander Manufacturing Co. Rechargeable Battery #M007HFO · Traditional | Alexander Mfg. Co. | 11/12/1997SE |
| K791633 | UC-2000 Uterine Catherization SystemHFO · Traditional | Life Support, Inc. | 09/17/1979SE |
| K780487 | Fetal Monitoring SystemHFO · Traditional | Sonicaid, Inc. | 05/09/1978SE |
More from Sonicaid, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K954774 | Shielded Trocar (Obturator)HET · Traditional | 06/07/1996SE |
| K953548 | Laparoscopic Surgical InstrumentHET · Traditional | 09/19/1995SE |
| K944640 | Laparoscopic Surgical Instrument/Accessory KitFBQ · Traditional | 10/11/1994SE |
| K944104 | Gabris Laparoscopic Surgical KitsFBQ · Traditional | 09/13/1994SE |
| K944103 | Laparoscopic/Endoscopic InstrumentGCJ · Traditional | 09/12/1994SE |
| K930716 | Laparoscopic Cholecystectomy InstrumentationGCJ · Traditional | 07/23/1993SE |
Questions and answers
When was Laparoscopic/Endoscopic Instruement cleared by the FDA?
Laparoscopic/Endoscopic Instruement (K943989) received a 510(k) decision of Substantially Equivalent on September 12, 1994, 27 days after the submission was received.
What is the product code of K943989?
The FDA product code is HFO – Recorder, Pressure, Intrauterine, a Class II (moderate risk) device regulated under 21 CFR 884.2700.