510(k) K921006
- Device
- LAPAROSCOPIC RETRACTOR SYSTEM
- Applicant
- LAPAROMED CORP.
- 510(k) number
- K921006
- Product code
- GCS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-07-28
- Date received
- 1992-03-03
- Regulation
- 876.1500
- Classification name
- Endoscope, Battery-powered And Accessories
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAUL LUBOCK
- Address
- 9272 Jeronimo Rd., Unit 109 Irvine CA US 92718 92718
FDA Registration Numbers#
- 1923569
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GCS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K944062 | LAPRASCOPIC GRASPER | Instrument Makar, Inc. | 1995-02-23 |
| K944067 | PEANUT WAND, MODIFICATION | Ideal Medical, Inc. | 1994-12-08 |
| K933201 | AESCULAP TROCAR INSTRUMENT SET | Aesculap, Inc. | 1993-09-13 |
| K932762 | 10.0MM SUCTION/IRRIGATION PROBE & TUBING KIT | Inman Medical Corp. | 1993-08-31 |
| K933371 | IMC ENDOSCOPIC INSTRUMENT HOLDER | Inman Medical Corp. | 1993-08-06 |
| K924134 | LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS | Leisegang Medical, Inc. | 1993-07-02 |
| K931340 | GRASP FORCEPS/SCISSORS/NEEDLE HOLDER/DISSECTOR | Baxter Healthcare Corp | 1993-07-01 |
| K925276 | M.I.S. TROCAR-CANNULA | M.I.S. Technology, Inc. | 1993-05-24 |
Legacy Summary#
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FDA Review#
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