OP-CON Surgical Instruments #4

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K834174 ↗

FDA Product Code

HCZ

FDA applicant

Imm Enterprises , Ltd.

Device Class

Class II

Regulation

21 CFR Part 884.4530

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• H.R. Jakobi Surg. Instruments #9 48

  Class II

  FDA 510(k) K834179 Active Cleared 27 Jan 1984

• H.R. Jakobi Surg. Instruments #4 30/31

  Class I

  FDA 510(k) K834177 Active Cleared 27 Dec 1983

• Cat. 14-Clinical Toxiology Devices

  Class I

  FDA 510(k) K840318 Active Cleared 23 Apr 1984

• H.R. Jakobi Surg. Instruments #11 38/67

  Class I

  FDA 510(k) K834184 Active Cleared 27 Jan 1984

• Op-Con Surgical Instrument #9

  Class I

  FDA 510(k) K834169 Active Cleared 17 Jan 1984

• Jakobi Surgical Instruments #3 17/18/19

  Class I

  FDA 510(k) K834191 Active Cleared 22 Mar 1984

See all devices from Imm Enterprises, Ltd. →

• Are these instruments intended for single-use or can they be reused in multiple procedures?

  The OP-CON Surgical Instruments #4 are designed as reusable devices. Since they fall under standard surgical instrument guidelines, they must be sterilized and maintained according to established protocols between uses to ensure safety and functionality. This approach aligns with typical clinical practices for reusable gynecological forceps.

• What types of surgical procedures are these forceps primarily used for?

  These instruments are specifically designed for obstetric and gynecological procedures, where precise tissue manipulation and retrieval are required. The classification under FDA regulation 884.4530 and the medical specialty description confirm their intended use in these surgical contexts, such as during gynecological surgeries or obstetric interventions.

• How should these instruments be stored to maintain their integrity?

  While the data does not specify storage conditions explicitly, reusable surgical instruments like these typically require clean, dry, and protected storage to prevent contamination or damage. Following standard surgical instrument guidelines—such as keeping them in a sterile barrier pouch or dedicated storage case—is recommended to ensure they remain functional and safe for reuse.

• What regulatory pathway was followed for FDA clearance of these instruments?

  The OP-CON Surgical Instruments #4 received FDA clearance through a 510(k) submission, classified as a Class II medical device. The clearance was granted as Substantially Equivalent (SESE) following review by the Obstetrics/Gynecology advisory committee, indicating that the device met the regulatory standards for gynecological surgical forceps without requiring a new clinical trial.

• Are there multiple sizes or models of these forceps available?

  The data does not provide explicit details on varying sizes or models of the OP-CON Surgical Instruments #4, but the registration and product codes listed (e.g., HCZ) suggest multiple variants may exist within the broader product line. For precise sizing or model-specific information, consulting the manufacturer’s catalog or technical documentation would be necessary.