Jarit Surgical Instruments Catalog 615-330, 615-331, 615-334, 615-335, 615-338, 615-339

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K933728 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Jarit Endoscopes, 600-600; 600-630; 600-650; 680

  Class II

  FDA 510(k) K931878 Active Cleared 19 Aug 1993

• Cope Lung Forceps #305-218

  Class I

  FDA 510(k) K771624 Active Cleared 6 Sep 1977

• Jarit Surgical Instruments

  Class II

  FDA 510(k) K931959 Active Cleared 5 Oct 1993

• Jarit Recommended Sinus Instruments

  Class II

  FDA 510(k) K944670 Active Cleared 2 Feb 1995

• Leiningeo Aortic Punch #310-395 & 397

  Class I

  FDA 510(k) K771625 Active Cleared 12 Sep 1977

• Jarit Hulka Uterine Tenaculum Forceps

  Class II

  FDA 510(k) K082349 Active Cleared 21 Nov 2008

See all devices from J. Jamner Surgical Instruments, Inc. →

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

  These instruments are explicitly labeled as reusable surgical tools, meaning they are intended for repeated use in multiple surgical procedures after proper cleaning, sterilization, and maintenance. Since they are not described as disposable, they must be processed according to standard reusable surgical instrument protocols to ensure safety and functionality.

• What are the key differences between the model numbers in this catalog, particularly in terms of size?

  The catalog includes multiple models with varying specifications, such as overall length (527 mm) and working length (435 mm) for certain variants. While exact dimensions for each model (615-330, 615-331, etc.) are not detailed beyond these examples, the differences likely relate to functional design (e.g., blade shape, jaw width, or ergonomics) rather than just length. For precise sizing, refer to the manufacturer’s technical documentation or request a detailed size comparison.

• How are these instruments authorized for use in the U.S., and what does the FDA clearance indicate about their safety and effectiveness?

  These instruments received FDA 510(k) clearance (K933728) under the Substantially Equivalent (SESE) determination by the Surgical Devices Panel (SU). This means the FDA concluded that they have the same intended purpose, technological characteristics, and performance as a legally marketed predicate device, ensuring they meet applicable safety and effectiveness requirements. The clearance does not imply clinical superiority but confirms compliance with regulatory standards for electrosurgical cutting and coagulation accessories.

• What types of surgical procedures are these instruments typically used for, and why are they considered essential in those settings?

  These instruments are electrosurgical cutting and coagulation devices, designed for procedures requiring precise tissue removal and hemostasis—such as general surgery, plastic surgery, or dermatological interventions. The high-frequency electrical current allows surgeons to dissect tissue while simultaneously sealing blood vessels, reducing bleeding and improving procedural control. Their design supports applications where minimal trauma and efficient bleeding control are critical, like excisions, biopsies, or reconstructive surgeries.

• Are there any special storage requirements for these reusable instruments to maintain their performance and sterility?

  While the data does not specify exact storage conditions, reusable surgical instruments like these generally require clean, dry, and protected storage to prevent damage or contamination. They should be stored in a dedicated instrument tray or case, away from direct sunlight or extreme temperatures, and protected from sharp objects that could cause nicks or warping. Proper maintenance (e.g., lubrication, inspection) is also essential before each use to ensure functionality and sterility.